Description
Role: Quality Specialist/FDA/GxP/Pharma/Art Work and Labelling
Reference Nr.: 916044NC
Sector: Pharmaceutical
Location: Dublin, Co. Dublin
Start: ASAP
Duration: 11 months
Job Type: Contract
Role:
- Provide Quality support/oversight of artwork management/labelling change process to ensure clear requirements are defined and executed to enable release of artwork to CMO/print vendor
- Provide input to the Artwork and Labelling Quality Lead to make decisions regarding overall Quality strategy and priorities
- Escalate quality issues to the Artwork and Labelling Quality Lead when necessary
- Support resolution on areas identified as non-conformance related to area(s) of expertise
- Support gathering quality metrics
- Exercises judgement within defined procedures and practices to determine appropriate action
- Support general department activities as needed
Skills/Experience:
- Bachelor's degree
- 2-3 years in pharmaceutical manufacturing/quality operations
- Packaging and labeling experience
- Change control experience preferred- Trackwise 8
- General knowledge of FDA regulations and GxPs
- Must be self-driven and have the ability to operate with limited direction
- Strong decision maker
- Detailed oriented
- ability to meet deadlines
- Implement and demonstrate good leadership skills
- Good communication skills
About Us:
Since the foundation of our parent company - ITech Consult AG in 1997, we have continually extended our network of computer experts. ITech Consult has offices in Switzerland, Germany, UK and Ireland. Freelance IT specialists benefit from our comprehensive service offerings: including job evaluation, support in the application phase through to legal requirements, setting up of Irish Ltd Companies and on-going administrative support with our clients.